NPPA Reviews Data From Coronary Stent Makers

New Delhi, 19 March 2019: The National Pharmaceutical Pricing Authority (NPPA) has started reviewing sales data from coronary stent manufacturers and importers ahead of revising prices in accordance with the wholesale price index (WPI) of the previous year. The current ceiling prices are valid only till the end of this month. 

In a circular issued last week, the national drug price regulator had directed firms to furnish details such as price to distributor or stockiest, category-wise maximum retail price (MRP) and the quantity sold in the last calendar year. Once finalised, the ceiling prices will be applicable to all coronary stents available for sale in the country’s trade channel including bare metal stents (BES) and drug eluting and bioresorbable vascular scaffold. After reviewing the sales data, the government is expected to hold discussions with industry stakeholders before arriving at the ceiling price for the next one year. 

Last year, the government had marginally hiked the MRP of BES from Rs.7,260 to Rs.7,660 and slashed the price of drug-eluting stents (DES) and biodegradable stents to Rs.27,890 from Rs.29,600. After examining market statistics, the regulator was of the view that "cardiac stents, being an essential drug under Schedule I of DPCO 2013 and part of NLEM 2015 having paramount importance on public health, need to continue to be kept under price regulation in larger public interest". The regulator has also refused to provide separate sub-category and higher ceiling price for latest-generation biodegradable stents despite several requests by multinational manufacturers. Biodegradable stents now have the ceiling price of DES only. The manufacturers are allowed to add goods and services tax and no other charges in the calculation of MRP, if they have actually paid such taxes or if it is payable to the government on the ceiling price specified.

The NPPA is considering stent price revision just weeks after a decision by the US administration to revoke its Generalised System of Preferences (GSP) tax concessions to India citing “trade barriers that create serious negative effects on United States commerce”. The Central government slashed prices of medical devices such as knee implants and coronary stents by up to 75 per cent to make them more affordable. The US has been pressing India not to extend these price caps. Last year, following petitions filed by US medical device manufacturers, the office of the USTR initiated a GSP benefits eligibility review of India, which has resulted later in withdrawal of concessions. Three US medical device majors - Abbott, Boston Scientific and Medtronic - had petitioned the US government through the industry association AdvaMed for withdrawing GSP benefits over the medical device pricing policy.

According to minister of state for chemicals and fertilisers Mansukh L. Mandaviya, the decision to fix stent ceiling prices has helped 10 lakh heart patients in India save around Rs.8,000 crore. Moreover, 1.5 lakh patients saved about Rs.2,000 crore since the price fixation of knee implants in August 2017. Pharmabiz